510(k) Report

510(k) · Cleared

Recalled · 2009

Transfx Intermediate External Fixation System,Transfx Small External Fixation System, Transfx Mini External Fixation

K990848510(k) TraditionalCleared May 17, 199963-day reviewClass II21 CFR 888.3030Recalls 8

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Immedica, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on May 17, 1999 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled 8 times.

Decided
May 17, 1999
Review
63 days
Class
Class II
Product code
LXT
Recalls
8
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2006: 1 descendant cleared2015: 1 descendant cleared1995200020052010201520202025
  1. This deviceK990848 Transfx Intermediate External Fixation System,Transfx Small External…Immedica, Inc. · 1999
  2. Descendant · cites it directly · 2 of its ownK131413 Xtrafix Small External Fixation SystemZimmer, Inc. · 2014
  3. Descendant · cites it directly · 1 of its ownK141697 Xtrafix External Fixation System, Xtrafix Small External Fixation…Zimmer, Inc. · 2014
  4. Descendant · 2 generations on · 0 of its ownK152484 FastFrame External Fixation System - Distal RadiusZimmer, Inc. · 2015
  5. Descendant · cites it directly · 0 of its ownK061759 Reprocessed External Fixation DeviceAscent Healthcare Solutions · 2006

Most influential descendants

Showing 4 of 4 · See all
  • K131413Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · cites it directly2descendants
  • K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · cites it directly1descendant
  • K152484FastFrame External Fixation System - Distal RadiusZimmer, Inc. · 2015 · 2 generations on0descendants
  • K061759Reprocessed External Fixation DeviceAscent Healthcare Solutions · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990848Transfx Intermediate External Fixation System,Transfx Small External Fixation…Immedica, Inc.1999—
+1K131413Xtrafix Small External Fixation SystemZimmer, Inc.2014—
+1K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc.2014—
+2K152484FastFrame External Fixation System - Distal RadiusZimmer, Inc.2015—
+1K061759Reprocessed External Fixation DeviceAscent Healthcare Solutions2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201420
201510
FIG. 1 — Lineage of K990848, 1999–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LXT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LXT device

  1. #1 K230067 Para-Fix External Fixation Systemscore 6.4 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131413Xtrafix Small External Fixation SystemZimmer, Inc.20142
K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc.20141
K061759Reprocessed External Fixation DeviceAscent Healthcare Solutions20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 1, 2009Not classifiedZ-1533-2009Process controlDrill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
May 1, 2009Not classifiedZ-1532-2009Process controlDrill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
May 1, 2009Not classifiedZ-1538-2009Process controlDrill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
May 1, 2009Not classifiedZ-1534-2009Process controlDrill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
May 1, 2009Not classifiedZ-1535-2009Process controlDrill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
May 1, 2009Not classifiedZ-1536-2009Process controlDrill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
May 1, 2009Not classifiedZ-1537-2009Process controlDrill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
Feb 10, 2003Not classifiedZ-0907-03OtherMislabeled; wrong identification number on pin.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K131413 (Zimmer, Inc., 2014) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LXT devices

LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXT

1in 2023

2007: 12008: 12009: 12011: 12013: 22023: 1
2007high 2 (2013) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXT

Too few LXT 510(k)s in any year since 2007 to give a median.

Recalls per year · LXT

2in 2018

2007: 12009: 72018: 2
2007high 7 (2009) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LXT

7in 2025

2007: 262008: 582009: 412010: 332011: 852012: 422013: 392014: 362015: 352016: 382017: 662018: 732019: 402020: 322021: 242022: 212023: 182024: 272025: 7
2007high 85 (2011) · low 7 (2025)2025

MAUDE reports naming product code LXT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—126
20081—058
20091—741
20100—033
20111—085
20120—042
20132—039
20140—036
20150—035
20160—038
20170—066
20180—273
20190—040
20200—032
20210—024
20220—021
20231—018
20240—027
20250—07
20260—0—

What is it indicated for?

Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Immedica, Inc.

8 FDA decisions under this applicant name. See the company

  • K023575Concert CranioplastImmedica, Inc. · 2003
  • K013755Concert Radiopaque Bone CementImmedica, Inc. · 2002
  • K003205Transfx Angled RodsImmedica, Inc. · 20007 recalls
  • K001228External Fixation Anchor PinImmedica, Inc. · 2000
  • K001084Trans FX Adjustable Pin to Bar ClampImmedica, Inc. · 2000

Recent decisions in LXT

The LXT category page

  • K230067Para-Fix External Fixation SystemNew Paradigm Biomedical · 2023
  • K131636Polarus ConnectAcumed, LLC · 2013
  • K132704Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowBiomet · 20131 recall
  • K112345Distal Volar Radius Plating SystemsMedos International SARL · 20114 recalls
  • K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth…DePuy Orthopaedics, Inc. · 2009

https://510kreport.com/device/K990848 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990848: Transfx Intermediate External Fixation System,Transfx Small External Fixation System, Transfx Mini External Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990848

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026